Asthma Symptom Management Through Mindfulness Training

描述（由申请人提供）：哮喘是四种最常见的成人慢性疾病之一。它影响了7.3%（1640万）的美国成年人，直接医疗成本和生产力损失高达180亿美元。控制症状和改善患者的生活质量（QOL）是哮喘管理的目标，并要求患者准确识别其症状。但是，患者的症状报告与他们的肺功能之间的低一致性导致疾病管理错误。哮喘患者识别其症状的准确性受到情绪因素的影响，并且由于高负性情绪与低内感受准确性以及更差的哮喘症状和哮喘身体健康相关，因此哮喘患者中普遍存在的频繁精神困扰被认为导致难以区分压力/痛苦症状与哮喘症状。正念训练教导人们识别和区分经验的组成部分（思想，感觉，感觉/症状），并与呼吸阻力的感知准确性增加和情感消极性减少有关。因此，它有可能改善患者对哮喘症状和压力/痛苦的区分，从而改善哮喘管理、控制和QOL。一项广泛使用的正念训练计划（正念减压（MBSR））的试点RCT（N=84），旨在探索轻度、中度或重度持续性哮喘成人的这一假设。比较正念减压疗法和积极控制疗法的意向性治疗分析显示，总体生活质量有临床显著改善（p=0.01），哮喘症状也有重要改善（p=0.009），哮喘急救药物使用减少（p=0.001），焦虑（p=0.05），压力感知（p=0.01）和正念（p=0.01）。哮喘控制良好的患者比例也有了可喜的改善，所有的改善都在干预后持续了10个月。广泛采用这种有前途的辅助干预措施将需要更清晰的证据，关于哮喘控制和症状。因此，拟议RCT的主要目的是使用金标准测量方法，在256名轻度、中度或重度哮喘成人中测试MBSR与哮喘控制和症状的关键临床结局的积极对照。次要目的是评估该项目对哮喘QOL、肺功能、成本效益的影响，以及呼吸内感受性准确性对哮喘控制、QOL和药物使用的中介作用。在基线、6、12和18个月随访时进行评估。MBSR可在全国范围内使用，并由许多第三方付款人支付。如果发现哮喘控制和症状的持续和可信的改善，MBSR可能是传统医学治疗的一个有用的辅助手段，并有可能改善哮喘患者的生活。通过研究心理社会变量对哮喘控制的中介作用，该研究还产生了关于医学中身心和行为计划的变化和维持机制的新知识。

DESCRIPTION (provided by applicant): Asthma is one of the four most common adult chronic disorders. It affects 7.3% (16.4 million) U.S. adults and costs $18 billion in direct healthcare costs and lost productivity. Control of symptoms and improving patient's quality of life (QOL) are the goals in asthma management and require patients to accurately identify their symptoms. But the low congruence between patients' symptom reports and their pulmonary function leads to disease management errors. The accuracy with which asthma patients recognize their symptoms is affected by emotional factors, and because high negative affectivity is related to low interoceptive accuracy and worse asthma symptoms and asthma physical health, the frequent mental distress prevalent among asthmatics is thought to result in difficulty in distinguishing symptoms of stress/distress from those of asthma. Mindfulness training teaches people to recognize and distinguish among the components of experience (thoughts, feelings, sensations/symptoms) and is associated with increased perceptual accuracy of respiratory resistance, and reduced affective negativity. It thus has the potential to improve patient's discrimination between asthma symptoms and stress/distress, resulting in improved asthma management, control and QOL. A pilot RCT (N=84) of a widely-available mindfulness training program (Mindfulness-Based Stress Reduction (MBSR)) to explore this hypothesis in adults with mild, moderate or severe persistent asthma. Intent to treat analyses comparing MBSR to an active control program showed clinically significant improvements in overall QOL (p=0.01), as well as important improvements in asthma symptoms (p=0.009), reduced use of asthma rescue medication (p=0.001), anxiety (p=0.05), perceived stress (p=0.01), and mindfulness (p=0.01). Promising improvements in the percentage of patients with well-controlled asthma also were found. All improvements were sustained 10 months post-intervention. Widespread adoption of this promising adjunct intervention will require sharper evidence regarding asthma control and symptoms. The primary aim of the proposed RCT is therefore to test MBSR against an active control on the key clinical outcomes of asthma control and symptoms using gold standard measures with 256 adults with mild, moderate or severe asthma. Secondary aims evaluate the program's effect on asthma QOL, lung function, cost-effectiveness, and the mediating effect of respiratory interoceptive accuracy on asthma control, QOL, and medication use. Assessments are at baseline, 6-, 12-, and 18-month follow-up. MBSR is available nationwide and covered by many third-party payers. If sustained and credible improvements in asthma control and symptoms are found, MBSR could be a useful adjunct to traditional medical treatment and would have the potential for improving the lives of people with asthma. By examining the mediating effects of psychosocial variables on asthma control, the study also generates new knowledge on mechanisms of change and maintenance in mind-body and behavioral programs in medicine.